Catalog Number

-

Brand Name

HARVEST®

Version/Model Number

51400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BK120038,BK120038

Product Code

ORG

Product Code Name

Platelet and plasma separator for bone graft handling

Public Device Record Key

2195bd7b-26e1-401c-a632-d9231815a9bf

Public Version Date

September 02, 2022

Public Version Number

7

DI Record Publish Date

September 15, 2016

Package DI Number

35020583514004

Quantity per Package

4

Contains DI Package

05020583514003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-